Dronabinol is a naturally occurring compound found in Cannabis saliva L., having the following chemical structure:
(6aR-trans)-6a,7,8,10a-tetrahyrdo-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol
Dronabinol, also known as delta-9-tetrahydrocannabinol or Δ9-THC, has found its place in recent years in a synthetically produced form as an approved therapy for various conditions, such as chemotherapy-induced nausea and vomiting in patients who have failed to respond adequately to conventional anti-emetics.
A currently marketed dronabinol composition is a soft gelatin capsule (dronabinol solution in sesame oil encapsulated in a soft gelatin shell). Dronabinol soft gelatin capsules lack stability at room temperature, and therefore must be stored in a cool environment between 8° C. and 15° C. or refrigerated.
There remains a need in the art for a dronabinol oral solid dosage form which is stable for extended periods of time at room temperature.
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